XTalks

MARCH 22, 2021

Maverick’s COBRA platform is used to engineer protein-based therapies that target T cells in the tumor microenvironment to trigger their activation. The biotech acquisition deal includes Five Prime’s prime asset bemarituzumab, which is a first-in-class anti-FGFR2b antibody.

Life Science 110

Life Science Development Marketing Engineer 110

Trialfacts

SEPTEMBER 15, 2024

VIKTORIA-1 is a clinical trial aimed at evaluating gedatolisib, a new investigational drug for patients with HR+/HER2-, Stage 3 or 4 breast cancer. More Study Details Study Locations About the Study Breast cancer represents a significant challenge, and advancing treatment options is crucial for patients facing this disease.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Genetics 52

The Pharma Data

JANUARY 14, 2021

HR (95% CI): 0.68. HR (95% CI): 0.54 (0.33, 0.87). HR (95% CI): 0.44 (0.25, 0.77). HR (95% CI): 0.58; (0.35, 0.95); p=0.027. HR (95% CI): 0.44 (0.25, 0.77). HR (95% CI): 0.58; (0.35, 0.95); p=0.027.

Trials 52

Trials HR Containment Development 52

The Pharma Data

MAY 4, 2021

months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; months (HR=0.76, 95% CI: 0.54–1.09). PD-L1 is a protein expressed on tumour cells and tumour-infiltrating cells, which suppresses the immune response and enables tumour cells to avoid detection by binding to proteins on the surface of immune cells. receptors.

Protein 52

Protein HR In-Vitro Medicine 52

The Pharma Data

SEPTEMBER 10, 2021

Patients treated with a short course of five cycles of tremelimumab, an anti-CTLA4 antibody, over 16 weeks in addition to Imfinzi and chemotherapy experienced a 23% reduction in the risk of death versus a range of chemotherapy options (based on a hazard ratio [HR] of 0.77; 95% CI 0.65-0.92; 0.92; p=0.00304). Median OS was 14.0

HR 52

HR Trials Medicine Immune Response 52

The Pharma Data

SEPTEMBER 18, 2020

The recommendation from the CHMP is based on results from the Phase III IMbrave150 study, which showed that Tecentriq in combination with Avastin reduced the risk of death (overall survival [OS]) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42–0.79; 0.76; p<0.0001), compared with sorafenib.

Medicine 52

Medicine HR In-Vitro Protein 52

The Pharma Data

SEPTEMBER 19, 2020

months in median OS with Tecentriq plus nab-paclitaxel, compared with placebo plus nab-paclitaxel (hazard ratio [HR]=0.67; 95% CI: 0.53–0.86). The OS data showed a negative trend; however, the study was not powered for the secondary endpoint of OS, and OS data were immature at time of analysis (initial HR=1.55 [95% CI: 0.86-2.80]

HR 52

HR Medicine In-Vitro Development 52

The Pharma Data

AUGUST 3, 2021

The study showed that treatment with Tecentriq, following surgery and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) 0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1?1%, 1%, compared with best supportive care (BSC). months for BSC.

HR 52

HR Antibody FDA Approval Development 52

The Pharma Data

SEPTEMBER 16, 2020

Data will also be presented for two of our investigational hormone receptor (HR)-positive breast cancer treatments, both of which target the PI3K/AKT signalling pathway, a key driver of cancer cell growth and proliferation. HR-positive breast cancer. GDC-0077 is our next generation investigational PI3K? Ipatasertib.

HR 52

HR Medicine Hormones Trials 52

The Pharma Data

JANUARY 15, 2021

In the DESTINY-Gastric01 trial, patients (n=126) in the Enhertu treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; 4.3] (HR=0.47; 95% CI 0.31-0.71) is a HER2 directed antibody drug conjugate (ADC).

Medicine 52

Medicine Trials Antibody HR 52

XTalks

MAY 2, 2024

billion After Biogen and Eisai’s Aduhelm (aducanumab) and Leqembi (lecanemab), donanemab is Eli Lilly’s answer in the beta-amyloid-lowering class of monoclonal antibodies. The companies followed it up with a second BLA submission in patients with HR+, HER2– breast cancer that has been previously treated with systemic therapy.

Drugs 52

Drugs FDA Approval Sales Vaccine 52

Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern.

Research 112

Research Vaccine Vaccination Drugs 112

The Pharma Data

SEPTEMBER 28, 2021

In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the danger of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) Data from the IMpower010 trial were published simultaneously within the Lancet. 0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1?1%,

Clinical Trials 52

Clinical Trials Clinical Trials Trials HR 52

XTalks

DECEMBER 4, 2020

Imaging techniques such as ultrasound and computerized tomography (CT) are used to visualize structural changes or abnormalities resulting from kidney damage or congenital causes, while urinalysis can be used to detect blood or protein in the urine — another indication of kidney damage. Developed in 1999 2. Expressed in mL/min/1.73m 2.

Trials 52

Trials Clinical Trials Clinical Trials Antibody 52

The Pharma Data

APRIL 23, 2021

Results of the VIALE-A study showed Venclyxto plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS), compared to azacitidine alone (HR=0.66; 95% CI: 0.52, 0.85; p<0.001). Venclyxto blocks the BCL-2 protein and works to help restore the process of apoptosis. The median OS was 14.7 months (95% CI: 11.9,

Medicine 40

Medicine In-Vitro Antibody Development 40

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 6.45 billion in 2022, a 32.44

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

FEBRUARY 5, 2024

Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Darzalex (Daratumumab) Darzalex 2022 Sales: $7.977 billion Company/Developer: Janssen Biotech, Inc.,

FDA Approval 101

FDA Approval Drugs Sales Development 101

The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. vs. 11.4%) (p < 0.0001).

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

JUNE 18, 2021

1 With up to seven years of follow-up, progression-free survival (PFS) benefit with single-agent IMBRUVICA was sustained (Hazard Ratio [HR] 0.160 [95 percent Confidence Interval (CI): 0.111–0.230]). The BTK protein sends important signals that tell B cells to mature and produce antibodies. 1 Additionally, at 6.5

FDA Approval 40

FDA Approval Medicine Development Trials 40

XTalks

FEBRUARY 5, 2024

Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Darzalex (Daratumumab) Darzalex 2022 Sales: $7.977 billion Company/Developer: Janssen Biotech, Inc.,

FDA Approval 52

FDA Approval Drugs Sales Development 52

The Pharma Data

APRIL 26, 2022

AstraZeneca’s Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 0.93; p=0.0035).4

Immune Response 52

Immune Response Trials Protein Antibody 52

The Pharma Data

JANUARY 4, 2021

months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). TIGIT and PD-L1 are proteins that play a role in suppression of the immune system. Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1.

Medicine 52

Medicine Immune Response Protein Gene 52

The Pharma Data

APRIL 7, 2021

months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months (HR: 0.51; 95% CI: 0.41-0.62; Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse. months from 1.7 0.54; p<0.0001).

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

AUGUST 9, 2021

Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1).

Trials 52

Trials Medicine Development Clinical Trials 52

The Pharma Data

MARCH 23, 2021

For OS and PFS, KEYTRUDA plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; 0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; for the placebo arm, with a HR of 0.62 (95% CI, 0.49-0.78; for the placebo arm, with a HR of 0.86 (95% CI, 0.68-1.10).

HR 52

HR FDA Approval Containment Genome 52

The Pharma Data

APRIL 14, 2021

Trodelvy is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER 2-) metastatic breast cancer and metastatic non-small cell lung cancer. More information on TROPiCS-04 is available at [link]. About Trodelvy. About the TROPHY U-01 Study.

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

XTalks

AUGUST 10, 2022

Enhertu is an antibody-drug conjugate (ADC) consisting of Roche’s Herceptin (trastuzumab), a monoclonal antibody against HER2 (human epidermal growth factor receptor 2), and the topoisomerase I inhibitor deruxtecan. The trial included 494 hormone receptor positive (HR+) patients and 63 hormone receptor negative (HR-) patients.

FDA Approval 98

FDA Approval HR Hormones Antibody 98

The Pharma Data

MAY 4, 2021

Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.;

Vaccine 40

Vaccine Vaccination Production Sales 40

XTalks

NOVEMBER 26, 2024

Why it sold so well: Imbruvica is a kinase inhibitor that targets Bruton’s tyrosine kinase (BTK), a crucial protein in the B-cell receptor signaling pathway. This protein plays a vital role in the survival, growth and movement of malignant B cells. for a 70 mg/mL oral suspension and going up to $22,690.52 months, compared to 14.5

Sales 105

Sales FDA Approval Drugs Marketing 105